Uganda yesterday launched clinical trials to test the effectiveness and safety of a ring containing an anti-retroviral drug, which is inserted in the vagina to prevent HIV infection in women.
If successful, the research in five African countries will give hope to women to get protection against infection without compromising adherence to the drug.
The other countries participating in the trials jointly conducted with the US national Institute of Health (NIH), are Malawi, Zimbabwe, Zambia and South Africa.
A total of 3,476 participants are expected to take part in the trials, 200 of whom will be from Uganda.
The MTN 020 study, which is otherwise called “A Study to Prevent Infection with a Ring for Extended Use (Aspire)”, aims at determining whether the drug dapivirine can safely prevent HIV infection when continuously released in the vagina from a silicone ring replaced once a month.
Researchers, including doctors from Uganda, the US and the other countries involved in the trials, on Tuesday announced the start of the trial processes during the 19th International AIDS conference in Washington DC.
When inserted, the ring releases protective medication all the time and so far there are no side effects.
The researchers said there is also no evidence of reproductive toxicity, but they added that they will monitor the participants and if any falls pregnant, they will discontinue her from the trial and monitor her.
The doctors said they expect the women involved in the trial will be using effective birth control methods.
They said the ARV ring does not contain birth control substances.
The trials in the other four countries will start in a few months, according to the researchers.
The researchers who announced the trials in Washington included Carl
W. Dieffenbach, Zeda F. Rosenberg. Saidi Kapiga, Sharon Hillier, Jarred Baeten, Linda Gail-Bekker, Annalene Nel, Philippa Musoke and Carol Onyango.
In Uganda, the screening of the participants started yesterday with three women out of the required 200. The participants will be assigned at random to receive either a silicone ring containing 25 miligrammes of dapivirine or a placebo silicon ring.
Neither the participants nor study team will know who received which type of ring. Participants will be instructed to insert a new ring every four weeks for at least 12 months, according to the researchers.
The women will stay in the study for a year or two and the possible results are expected in 2014 or early 2015. The women will be required to observe adherence to the ring.
This is the third stage of the study. The first stages were the studies done on animals in the lab followed by a smaller one on human beings.
The third one is the bigger one involving this number of women.
The study is funded by the National Institute of Allergy and Infectious diseases (NIAID), the Eunice Kennedy Shriver National Institute on Child Health and Human Development and the National Institute of Mental Health.
The three are part of the national institutes of health.
They are being sponsored in the study by the International Partnership of Microbicides.
NIAID director Anthony S. Fauci said in a press conference yesterday that what they are hoping for are scientifically proven forms of HIV prevention that women can control.
The ASPIRE trial will be led by protocol chair Baeten, who is an associate professor of global health at the University of Washington in Seattle; and protocol co-chair,
Thesla Palanee, the director of network trials at the Wits
Reproductive Health and HIV Institute in Johannesburg, South Africa.
Statistics show that half of the world’s HIV-infected population is female, while in Africa, 60% of the infected adults are women and most of them get it through unprotected sex.
The researchers said since many women cannot negotiate male condom use with their sexual partners, they need a form of HIV prevention they can use independently and regularly and can be implemented discreetly.
Microbicides are antimicrobial products applied to the vagina to prevent HIV transmission during sexual intercourse.
They kill or weaken the virus by strengthening the body’s defence system, blocking infection or preventing infection from spreading.
These are vaginal rings inserted to slowly release ARV drugs, in this case dapivirine, providing women with monthly protection.
Dapivirine is an ARV drug that works by preventing the HIV virus from replicating its genetic material after it enters a healthy cell. Dapivirine has been tested in several trials both as vaginal gel and ring formulations and also in oral formulations and showed a good safety profile.
Benefits of the ring
One ring is used for a month, unlike the gels that require regular application. The month-long duration supports women to use it consistently thereby increasing effectiveness
The ring is convenient and discreet
According to IPM studies, the ring is acceptable to women in Africa
The ring is physically stable, durable and easy to distribute
The ring delivers the ARV locally where it is needed with low systemic drug absorption.
Source: International Partnership for Microbicides
By Anne Mugisa, The New Vision